Cardioprotective Effects of Electroacupuncture Pretreatment Against Coronary Stenting

Not Applicable

• Conditions: Myocardial Injury
• Interventions: Procedure: Electroacupuncture stimulation; Procedure: No intervention

• Registration Number: NCT01020942
• Lead Sponsor: Xijing Hospital

Brief Summary

Myocyte necrosis as a result of elective percutaneous coronary intervention (PCI) occurs in approximately one third of cases and is associated with subsequent cardiovascular events. This study assesses the ability of electroacupuncture (EA) pretreatment to attenuate cardiac troponin I (cTnI) release after elective PCI.

Detailed Description

Elective percutaneous coronary intervention (PCI) is associated with troponin release in approximately one third of cases.Troponin release is a sensitive and specific marker of myocyte necrosis and infarction resulting from a form of ischemia/reperfusion injury, downstream embolization of atheromatous material, and coronary side-branch occlusion. A number of studies have demonstrated that procedure-related troponin release is associated with subsequent cardiovascular events.

Transient sublethal episodes of ischemia before a prolonged ischemia/reperfusion injury, known as ischemic preconditioning (IPC), have been shown to reduce the extent of myocardial infarction (MI).Electroacupuncture (EA) stimulus, as a pretreatment method, limits MI size in animal models. However, there are limited outcome to demonstrate protection from EA pretreatment during PCI. The present study investigated the ability of EA pretreatment to attenuate cardiac troponin I (cTnI) release after elective PCI in a single-center, randomized controlled trial.

Study Timeline

• Study First Submitted: 2009-11-24
• Study First Submitted QC: 2009-11-25
• Study First Posted: 2009-11-26
• Study Start: 2010-01
• Status Verified: 2011-11
• Primary Completion: 2011-12
• Last Update Submitted: 2011-12-15
• Last Update Posted: 2011-12-16
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• All patients > 18 of age who are undergoing elective PCI and are able to give informed consent are eligible for study.

Exclusion Criteria

• Emergency PCI,
• Elevation of cTnI before PCI taken at the preadmission clinic,
• Women of child-bearing age,
• Nicorandil or glibenclamide use (preconditioning-mimetic and preconditioning blocking medication, respectively), and
• Severe comorbidity (estimated life expectancy < 6 months).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pretreatment	Electroacupuncture stimulation	-
Control	No intervention	-

Primary Outcome Measures

Name	Time	Method
The primary outcome was assessing whether EA pretreatment before elective PCI reduced cTnI concentration at 48 hours.	48 hours after PCI

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes were the effect of EA pretreatment on ischemic symptoms, ECG evidence of ischemia during coronary balloon occlusion, CRP,and major adverse cardiac events (MACE) at 6 months.	six months of PCI follow-up.

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China